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Students Learn from the Experts at GW’s International Regulatory Science Institute

November 3, 2016

In July, a group of regulatory industry experts gathered for four days on the George Washington University (GW) campus to attend the first international annual summer institute, “Issues & Trends in Regulatory Science.” The event, organized through a collaboration between the Regulatory Affairs Program at the GW School of Medicine and Health Sciences (SMHS) and the European Center of Pharmaceutical Medicine at the University of Basel, featured some of the industry’s most prominent leaders, including Frank Weichold, M.D., Ph.D., director of the Office of Critical Path and Regulatory at the FDA; Michael Morton, vice president of corporate regulatory affairs at Medtronic; Bernadette Dunham, D.V.M., Ph.D., former director of the Center for Veterinary Medicine at the FDA; Jonca Bull, M.D., director of the Office of Minority Health at the FDA; and Blair Childs, senior vice president of public affairs at Premier.

“GW, located in Washington D.C., is in a unique position to attract a first-rate faculty to provide high-quality regulatory education,” said Daniela Drago, Ph.D., director of the GW Regulatory Affairs program at SMHS. “This event brought together internationally recognized experts. It provided a forum for faculty and students to analyze current challenges and opportunities in the regulatory field. One of our goals is to promote that regulatory professionals, at the agencies and in the regulated industry, work synergistically to improve the quality of health care around the world.”

Specific topics included how health care products are cleared or approved for marketing; the future of drug and medical device innovations; how the reimbursement process works; pending legislation that might change the way health care is delivered; and the One Health Initiative that aims to improve health care for all. Challenges to medical technology innovation were also discussed, and innovative solutions were crafted for future consideration within the industry.

On the second day of the event, attendees toured the FDA campus in Silver Spring, Maryland. They also saw state-of-the-art equipment and facilities at the National Institutes of Health, and the books, paintings, and lecture halls in the National Library of Medicine. Leaders from each institution talked about their missions and responded to the students’ questions.

In addition to industry leaders and working professionals, the event drew a large number of rising regulatory affairs students from the United States and abroad, including those hailing from Switzerland, the United Kingdom, Germany, Austria, Italy, India, Egypt, and Saudi Arabia. Also in attendance were students from the GW Regulatory Affairs program at SMHS; the health care M.B.A. program in GW’s business school; the GW Milken Institute School of Public Health’s master of public policy program; the Ph.D. program at the GW School of Engineering and Applied Science’s Institute for Biomedical Sciences; and the Master of Medicines Development program at the University of Basel, Switzerland.

“It was an invaluable experience, and … I thought every minute of this conference was well worth the trip [from where I live in Colorado],” said Emily Swanson-Parker, a class of 2017 student in the SMHS Regulatory Affairs program. “I thought Dr. Drago and GW did an outstanding job of finding knowledgeable and engaging speakers and organizing the agenda from day to day, hour to hour; it was very carefully laid out. Because I have both a student and professional background, I can tell that they designed this conference with the student in mind. It wasn’t just your run-of-the-mill professional conference, and I think that’s what made this conference stand out.”